Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Endometrial Papillary Serous Carcinoma
Localized Unresectable Adult Primary Liver Cancer
Metastatic Gastrointestinal Carcinoid Tumor
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Papillary Serous Carcinoma
Pancreatic Alpha Cell Adenoma
Pancreatic Alpha Cell Carcinoma
Pancreatic Beta Islet Cell Adenoma
Pancreatic Beta Islet Cell Carcinoma
Pancreatic Delta Cell Adenoma
Pancreatic Delta Cell Carcinoma
Pancreatic G-cell Adenoma
Pancreatic G-cell Carcinoma
Pancreatic Polypeptide Tumor
Pulmonary Carcinoid Tumor
Recurrent Adult Primary Liver Cancer
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Cancer
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Regional Gastrointestinal Carcinoid Tumor
Stage IIIA Endometrial Carcinoma
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Endometrial Carcinoma
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Endometrial Carcinoma
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Stage IVA Endometrial Carcinoma
Stage IVB Endometrial Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer|
- Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]A 95% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.
- Progression free survival rate, defined as the proportion of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration [ Time Frame: 6 months ] [ Designated as safety issue: No ]A 95% confidence interval for the true response rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval) if there are censored patients.
- Overall survival [ Time Frame: Time from registration to death, assessed up to 3 years ] [ Designated as safety issue: No ]Time to event distributions will be estimated using the Kaplan-Meier method.
- Duration of response [ Time Frame: Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years ] [ Designated as safety issue: No ]Median duration of response and the confidence interval for the median duration will be computed.
- Time to disease progression [ Time Frame: Time from registration to disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Time from study entry to the date patients end treatment, assessed up to 3 years ] [ Designated as safety issue: No ]Time to treatment failure will be evaluated using the method of Kaplan-Meier.
- Incidence of adverse events, defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (temsirolimus, bevacizumab)
Patients receive temsirolimus IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Biological: bevacizumab
I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.
II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.
I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis.
Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.